Four Arm Food Effect Study of Fenofibric Acid Tablets

This study has been completed.
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00960856
First received: August 14, 2009
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.


Condition Intervention Phase
Healthy
Drug: Fenofibric Acid 105 mg Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Four Arm, Single-Dose, Food Effect Evaluation With 105 mg Fenofibric Acid Tablets Administered in a Fasted State and Three Different Fed Conditions, Low-Fat/Low Calorie Meal, Standard Meal, and High-Fat/High Calorie Meal

Resource links provided by NLM:


Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) [ Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration ] [ Designated as safety issue: No ]
  • Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration ] [ Designated as safety issue: No ]
  • The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenofibric Acid 105 mg - Low-Fat Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
Drug: Fenofibric Acid 105 mg Tablet
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
Experimental: Fenofibric Acid 105 mg - Standard Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast.
Drug: Fenofibric Acid 105 mg Tablet
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
Experimental: Fenofibric Acid 105 mg - High-Fat/High-Calorie Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
Drug: Fenofibric Acid 105 mg Tablet
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
Experimental: Fenofibric Acid 105 mg - Fasted State
Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours
Drug: Fenofibric Acid 105 mg Tablet
One 105 mg tablet administered after an overnight fast of at least 10 hours.

Detailed Description:

The primary objective of this study is to determine the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence. Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions. Blood samples will be drawn from all participants before dosing and for 72 hours post-dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults between the ages of 18 and 45
  • Non-smoking
  • Non-pregnant (post-menopausal, surgically sterile, or using effective contraceptive measures)
  • Body mass index (BMI) less than 30
  • Medically healthy on the basis of medical history and physical examination
  • Hemoglobin > or = to 12g/dL
  • Completion of the screening process within 28 days prior to dosing
  • Provision of voluntary written informed consent

Exclusion Criteria:

  • Recent participation (within 28 days) in other research studies
  • Recent significant blood donation or plasma donation
  • Pregnant or lactating
  • Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
  • Recent (2-year) history or evidence of alcoholism or drug abuse
  • History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  • Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
  • Drug allergies to fenofibric acid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960856

Locations
United States, North Dakota
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
  More Information

No publications provided

Responsible Party: Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00960856     History of Changes
Other Study ID Numbers: MPC-028-07-1009
Study First Received: August 14, 2009
Results First Received: August 27, 2009
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mutual Pharmaceutical Company, Inc.:
pharmacokinetics

Additional relevant MeSH terms:
Fenofibric acid
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014